Interventional device having an integrated embolic filter and associated methods

ABSTRACT

A percutaneous transluminal device, comprising an elongated catheter, an interventional device operably coupled to the proximal end of the catheter, a filter operably coupled to the distal end of the catheter, the filter movable between a collapsed and deployed position 218, and an actuator wire for deploying the collapsing the filter. The filter including a filter chassis comprising a movable collar a fixed collar and a tubular braided scaffolding coupled between the movable collar and the fixed collar. Each wire of the braided scaffolding moving independently with respect to the other wires between the movable collar and the fixed collar as the filter moves between the collapsed position and the deployed position.

RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application62/107,216, filed Jan. 23, 2015, U.S. Provisional Application62/107,449, filed Jan. 25, 2015, and U.S. Provisional Application62/109,388, filed Jan. 29, 2015. Each of these applications areincorporated by reference in their entireties for all purposes.

BACKGROUND OF THE INVENTION

Field of the Invention

This invention relates generally to interventional devices and, moreparticularly, to interventional devices having an integrated embolicfilter, as well as methods of making and using the same.

Description of the Related Art

The vascular bed supplies a constant flow of oxygen-rich blood to theorgans. In diseased vessels, blockages can develop that can reduce bloodflow to the organs and cause adverse clinical symptoms up to andincluding fatality. Diseased vessels can comprise a range of materialfrom early-stage thrombosis to late-stage calcified plaque.

Angioplasty can be described as a catheter-based procedure performed bya physician to open up a stenosed vessel and restore blood flow. Anentry site can be opened, for example, in the patient's groin, arm, orhand, and a guide wire and catheter can be advanced under fluoroscopicguidance to the location of the blockage. A catheter having a smallballoon adjacent its distal end can be advanced under fluoroscopicguidance until the balloon lies within the stenosed region. The ballooncan be then inflated and deflated one or more times to expand thestenosed region of the artery.

Angioplasty is one example of a vascular intervention that can releaseembolic particles down-stream from a stenosed or otherwise compromisedlocation during intervention. These embolic particles can result inadverse clinical consequences. It has been shown beneficial to trapthese embolic particles to prevent them from traveling downstream withblood flow to the capillary bed (e.g., Baim D S. Wahr D, George B, etal., Randomized trial of a distal embolic protection device duringpercutaneous intervention of saphenous vein aorta-coronary bypassgrafts, Circulation 2002; 105:1285-90).

In addition to balloon angioplasty, stenoses can also be treated withstents and with mechanical thrombectomy devices. These devices are alsoprone to releasing embolic particles downstream from a stenosed locationduring intervention.

Systems available today used to catch these embolic particles consistprimarily of distal filter systems or occlusion balloon systems. Distalfilter systems are on guidewires, as are distal balloon occlusionsystems. Proximal balloon occlusion systems are on a guide catheter orsheath. These systems suffer shortcomings related to simplicity of use.Embolic protection guidewires also suffer from flexibility and stabilityproblems that render the protected angioplasty procedure relatively moredifficult in many cases. In the case of saphenous vein grafts, theproblems relate specifically to aorto-ostial lesions, where theguidewire may not be long enough to provide support, or distal veingraft lesions, where there can be not enough of a landing zone for thefilter. The latter can be a problem as currently available filtersystems can have a considerable distance between the treatment balloonand the distal filter. This distance can be a problem not only in distalvein graft lesions, but also in arterial stenoses in which there can bea side branch immediately after the stenoses. In such cases, the filtercan often be deployed only distal to the side branch, thus leaving theside branch unprotected from embolic particles.

Accordingly, a need exists for improved interventional devices having anintegrated embolic filter as well as methods for making an using thesame.

SUMMARY

It is to be understood that this summary is not an extensive overview ofthe disclosure. This summary is exemplary and not restrictive, and it isintended to neither identify key or critical elements of the disclosurenor delineate the scope thereof. The sole purpose of this summary is toexplain and exemplify certain concepts of the disclosure as anintroduction to the following complete and extensive detaileddescription.

In one aspect, the present disclosure describes a percutaneoustransluminal device comprising an elongated catheter having alongitudinal axis, a proximal end portion, a distal end portion, and anouter side wall; an interventional device operably coupled to the distalend portion of the catheter; and a filter operably coupled to the distalend portion of the catheter, wherein the filter can be selectivelycollapsible and expandable about and between a collapsed position and adeployed position. In one aspect, the filter can comprise a filterchassis operably coupled to a filter membrane. The filter chassis cancomprise a movable collar slidably coupled to the catheter, a fixedcollar spaced from the movable collar relative to the longitudinal axisof the catheter and immovably coupled to the catheter, and a tubularbraided scaffolding comprising a plurality of wires and having a firstend coupled to the movable collar and an opposed second end coupled tothe fixed collar, wherein each wire of the plurality of wires extendsbetween the first and second ends of the braided scaffolding, whereineach wire of the plurality of wires moves independently, or,alternatively, slides independently, with respect to the other wiresbetween the movable collar and the fixed collar as the filter movesbetween the collapsed position and the deployed position. In anotheraspect, each wire of the plurality of wires can further comprise atleast one crossover portion and at least one non-crossover portion and,in a further aspect, the filter membrane can be selectively attached toa plurality of the non-crossover portions. In another aspect, thecatheter further comprises a lumen and a port in communication with thelumen, the port comprising an aperture in the outer side wall of thecatheter located in between the fixed collar and the movable collar, andthe lumen extending from the proximal end portion of the catheter to theport. It is contemplated that the device further comprises an actuatorwire having a proximal and distal ends, wherein at least a portion ofthe actuator wire extends through the lumen of the catheter, and whereinthe distal end of the actuator wire exits the lumen of the catheterthrough the port and is coupled to the movable collar. In one aspect,when the filter is in the collapsed position, pulling on the proximalend of the actuator wire exerts a force on the movable collar in adirection relative to the longitudinal axis of the catheter that movesthe movable collar toward the fixed collar and wherein selectivemovement of the movable collar towards the fixed collar causes a centralportion of the filter chassis to radially expand thereby selectivelyexpanding the filter toward the deployed position.

In another aspect, the present disclosure describes a percutaneoustransluminal device comprising an elongated catheter having alongitudinal axis, a proximal end portion, a distal end portion, and anouter side wall, an interventional device operably coupled to the distalend portion of the catheter, and a filter operably coupled to the distalend portion of the catheter, wherein the filter can be selectivelycollapsible and expandable about and between a collapsed position and adeployed position. In one aspect, the filter can comprise a filterchassis comprising a tubular braided scaffolding having a distal endcoupled to a movable collar that is slidably coupled to the catheter andhaving a proximal end that is coupled to a fixed collar that is spacedfrom the movable collar relative to the catheter longitudinal axis andimmovably coupled to the catheter. In another aspect, the braidedscaffolding can have a shape memory that urges the filter into thecollapsed position. It is further contemplated that the braidedscaffolding can have a central portion having a maximal radialdisplacement from the catheter longitudinal axis, or apex, that isgreater than a target vessel radius when the filter is in the deployedposition. In another aspect, the catheter can further comprise a lumenand a port in communication with the lumen, the port comprising anaperture in the outer side wall of the catheter located in between thefixed collar and the movable collar, and the lumen extending from theproximal end portion of the catheter to the port. It is contemplatedthat the device can further comprise an actuator wire having a proximaland distal ends, wherein at least a portion of the actuator wire extendsthrough the lumen of the catheter, and wherein the distal end of theactuator wire exits the lumen of the catheter through the port and canbe coupled to the movable collar. In one aspect, when the filter is inthe collapsed position, pulling on the proximal end of the actuator wireexerts a force on the movable collar in a direction relative to thelongitudinal axis of the catheter that moves the movable collar towardthe fixed collar. It is contemplated that selective movement of themovable collar towards the fixed collar causes the filter to selectivelyexpand, thereby allowing the filter to conformably appose an inner wallof the target vessel and, in the selectively expanded configuration, thefilter captures substantially 100% of embolic particles having aparticle size of at least 150 microns while remaining substantiallypatent during operation of the angioplasty treatment device and at leastuntil the filter is collapsed for removal of the angioplasty device fromthe vessel.

Additional features and advantages of exemplary implementations of theinvention will be set forth in the description which follows, and inpart will be obvious from the description, or may be learned by thepractice of such exemplary implementations. The features and advantagesof such implementations may be realized and obtained by means of theinstruments and combinations particularly pointed out in the appendedclaims. These and other features will become more fully apparent fromthe following description and appended claims, or may be learned by thepractice of such exemplary implementations as set forth hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate aspects and together with thedescription, serve to explain the principles of the methods and systems.

FIG. 1 provides a side view of an example percutaneous transluminaldevice illustrating the filter in a collapsed position;

FIG. 2 provides a side view of the percutaneous transluminal device ofFIG. 1 illustrating the filter in a deployed position;

FIG. 3 provides a side view of an example percutaneous transluminaldevice illustrating the filter in a collapsed position;

FIG. 4 provides a side view of the percutaneous transluminal device ofFIG. 3 illustrating the filter in a deployed position;

FIG. 5 provides a side view of the percutaneous transluminal device ofFIG. 3 illustrating the filter and the interventional device in deployedpositions;

FIG. 6 provides a partial perspective view of the percutaneoustransluminal device and deployed filter of FIG. 3;

FIG. 7 provides two partial side views of the percutaneous transluminaldevice and deployed filter of FIG. 3 with varied braid configurations;

FIG. 8A provides a partial view of an example tubular braidedscaffolding;

FIG. 8B provides a partial view of an example tubular braidedscaffolding;

FIG. 9 provides a partial view of an example tubular braidedscaffolding;

FIG. 10 provides a partial view of an example filter membrane;

FIG. 11 provides a left side view of an example handle of a percutaneoustransluminal device;

FIG. 12 provides a right side perspective view of the handle of FIG. 11;

FIG. 13 provides a left side perspective view of the handle of FIG. 11;

FIG. 14 provides a right side partial section view of the handle of FIG.11;

FIG. 15 provides a right side section view of the handle of FIG. 11;

FIG. 16 provides from top left corner clockwise: the collapsed filter isshown in its initial state. The next figure shows the filter is deployedin an arterial model. The third figure shows the filter has capturedparticles. The last figure shows the filter is now collapsed trappingthe particles within the filter membrane;

FIG. 17 provides a table of Membrane Particulate Capture Efficiency TestResults;

FIG. 18 provides the deployed filter inside an arterial model;

FIG. 19 provides the collapsed filter in a curvature;

FIG. 20 provides an example percutaneous transluminal device.

DESCRIPTION OF THE INVENTION

The present invention can be understood more readily by reference to thefollowing detailed description, examples, drawing, and claims, and theirprevious and following description. However, before the present devices,systems, and/or methods are disclosed and described, it is to beunderstood that this invention is not limited to the specific devices,systems, and/or methods disclosed unless otherwise specified, as suchcan, of course, vary. It is also to be understood that the terminologyused herein is for the purpose of describing particular aspects only andis not intended to be limiting.

The following description of the invention is provided as an enablingteaching of the invention in its best, currently known aspect. To thisend, those skilled in the relevant art will recognize and appreciatethat many changes can be made to the various aspects of the inventiondescribed herein, while still obtaining the beneficial results describedherein. It will also be apparent that some of the desired benefitsdescribed herein can be obtained by selecting some of the featuresdescribed herein without utilizing other features. Accordingly, thosewho work in the art will recognize that many modifications andadaptations to the present invention are possible and can even bedesirable in certain circumstances and are a part described herein.Thus, the following description is provided as illustrative of theprinciples described herein and not in limitation thereof.

Reference will be made to the drawings to describe various aspects ofone or more implementations of the invention. It is to be understoodthat the drawings are diagrammatic and schematic representations of oneor more implementations, and are not limiting of the present disclosure.Moreover, while various drawings are provided at a scale that isconsidered functional for one or more implementations, the drawings arenot necessarily drawn to scale for all contemplated implementations. Thedrawings thus represent an exemplary scale, but no inference should bedrawn from the drawings as to any required scale.

In the following description, numerous specific details are set forth inorder to provide a thorough understanding described herein. It will beobvious, however, to one skilled in the art that the present disclosuremay be practiced without these specific details. In other instances,well-known aspects of vascular intervention and vascular interventionaldevices have not been described in particular detail in order to avoidunnecessarily obscuring aspects of the disclosed implementations.

As used in the specification and the appended claims, the singular forms“a,” “an” and “the” include plural referents unless the context clearlydictates otherwise. Ranges may be expressed herein as from “about” oneparticular value, and/or to “about” another particular value. When sucha range is expressed, another aspect includes from the one particularvalue and/or to the other particular value. Similarly, when values areexpressed as approximations, by use of the antecedent “about,” it willbe understood that the particular value forms another aspect. It will befurther understood that the endpoints of each of the ranges aresignificant both in relation to the other endpoint, and independently ofthe other endpoint.

“Optional” or “optionally” means that the subsequently described eventor circumstance may or may not occur, and that the description includesinstances where said event or circumstance occurs and instances where itdoes not.

Throughout the description and claims of this specification, the word“comprise” and variations of the word, such as “comprising” and“comprises,” means “including but not limited to,” and is not intendedto exclude, for example, other additives, components, integers or steps.“Exemplary” means “an example of” and is not intended to convey anindication of a preferred or ideal aspect. “Such as” is not used in arestrictive sense, but for explanatory purposes.

Disclosed are components that can be used to perform the disclosedmethods and systems. These and other components are disclosed herein,and it is understood that when combinations, subsets, interactions,groups, etc. of these components are disclosed that while specificreference of each various individual and collective combinations andpermutation of these may not be explicitly disclosed, each isspecifically contemplated and described herein, for all methods andsystems. This applies to all aspects of this application including, butnot limited to, steps in disclosed methods. Thus, if there are a varietyof additional steps that can be perdefined it is understood that each ofthese additional steps can be perdefined with any specific aspect orcombination of aspects of the disclosed methods.

Implementations described herein and depicted in FIGS. 1-15 provide fora percutaneous transluminal catheter-based device comprising aninterventional device and having an integrated filter. The integratedfilter comprises a flexible and conformable braided filter chassis thatenables the filter to conform to any vessel shape. Additionally, theintegrated filter can be configured to selectively move about andbetween a collapsed position and a deployed position. In another aspect,the unconstrained diameter of the filter in the deployed position can begreater than the target vessel. Accordingly, the integrated filter canbe selectively deployed to conformably oppose the vessel wall and createa zone of apposition between the filter and the vessel wall. The devicesdescribed herein enable many other advantages over prior art devices,such as improved flexibility, a lower profile, no buckling even in themost tortious vascular segments, improved traction through bends andpre-existing stents in steep angles, atraumatic deployment, 100% emboliccapture efficiency, and complete collapse to facilitate ease andpredictability of removal. These features and advantages, along withother features and advantages, will be discussed in detail herein.

In another aspect, the interventional device 212 can be an angioplastyinterventional device such as, for example and without limitation, anangioplasty balloon, a stent, a mechanical thrombectomy device, anatherectomy device and the like. In a further aspect, the atherectomydevice can comprise a rotational atherectomy device, a directionalatherectomy device or a combination thereof. In other aspects, theinterventional device can be selected to effect valvuloplasty, ablation,or the like.

In one aspect illustrated in FIGS. 1-7, the present disclosure describesa percutaneous transluminal device 200 comprising an elongated catheter202 having a longitudinal axis 204, a proximal end portion 206, a distalend portion 208, and an outer side wall 210; an interventional device212 operably coupled to the proximal end portion 206 of the catheter202, and a filter 214 operably coupled to the distal end portion 208 ofthe catheter 202, wherein the filter 214 can be selectively collapsibleand expandable about and between a collapsed position 216 and a deployedposition 218. An exemplary interventional device is shown in a deployedposition in FIG. 5. In light of the present disclosure, one skilled inthe art will appreciate that the interventional device 212 can belocated either proximal or distal to the filter 214 relative to thelongitudinal axis 204 of the catheter 202 depending on the particularsof the intervention for which the percutaneous transluminal device 200is configured to effect. Similarly, one skilled in the art willunderstand that the filter 214 should be oriented appropriately andlocated downstream from the interventional device 212 relative to theblood flow depending on the same. Solely for clarity of disclosure, thespecific case of angioplasty and a treatment device comprising a filterlocated distal to the treatment device is described and discussedherein; accordingly, neither of these features should be construed aslimiting aspects of this disclosure.

In another aspect, the filter 214 can comprise a filter chassis 220 anda filter membrane 222 operably coupled to the filter chassis 220. In oneaspect, the filter chassis 220 can comprise a movable collar 224slidably coupled to the catheter 202, a fixed collar 226 spaced from themovable collar 224 relative to the longitudinal axis 204 of the catheter202 and immovably coupled to the catheter 202, and a tubular braidedscaffolding 228 comprising a plurality of wires 230 and having a firstend 233 coupled to the movable collar 224 and an opposed second end 235coupled to the fixed collar 226. It is contemplated that each wire ofthe plurality of wires 230 of the tubular braided scaffolding 228extends between the first and second ends of the braided scaffolding228. In another aspect, each wire of the plurality of wires movesindependently, or, alternatively, slides independently, with respect tothe other wires between the movable collar and the fixed collar as thefilter moves between the collapsed position 216 and the deployedposition 218. In operation, as the distance between the movable collar224 and the fixed collar 226 along the catheter longitudinal axis 204 isselectively decreased, a central portion 232 of the tubular braidedscaffolding 228 will radially expand, causing the filter 214 toselectively expand towards the deployed position 218 and conformablyappose an inner wall of the target vessel thus achieving atraumaticfilter deployment. As one skilled in the art will appreciate in light ofthe present disclosure, the filter chassis 220 described herein enablesthe filter 214 to conform to the shape of the vessel and, when the atleast partially deployed filter radius 234 is greater than the targetvessel radius, conformably appose the vessel wall over a length referredto herein as a “zone of apposition” thereby increasing the captureefficiency of the deployed filter. Additionally, one skilled in the artwill appreciate in light of the present disclosure that the filterchassis 220 described herein can collapse completely against thecatheter side wall when the filter 214 is returned to the collapsedposition 216 and, also, will not buckle regardless of vessel tortuosity.

In another aspect, the plurality of wires 230 comprises from about 12 toabout 64 wires, more particularly, from about 12 to about 32 wires, and,most particularly, about 16 wires.

In another aspect, each of the plurality of wires 230 can be formed froma shape memory material. It is contemplated that the shape memorymaterial can be, for example and without limitation, nitinol or anyother shape memory material known in the art. In a further aspect, thebraided scaffolding 228 can have a shape memory corresponding to thecollapsed position 216 of the filter 214. Here, in operation, thebraided scaffolding 228 having a normally collapsed shape memory urgesthe filter into the collapsed position absent application of asufficient opposing force.

In another aspect, each wire of the plurality of wires 230 can be formedfrom a non-shape memory material, for example and without limitation, acobalt chromium alloy, a stainless steel alloy, a molybdenum rheniumalloy, a plastic, and the like. In yet another aspect, some of theplurality of wires 230 can be formed from a shape memory material andthe remainder of the plurality of wires can be formed from a non-shapememory material.

In another aspect, at least one of the plurality of wires 230 comprisesa substantially round cross-section. In a further aspect, the roundcross-section can range from about 60 to about 120 microns in diameter,more particularly, can be about 100 microns in diameter. In anotheraspect, at least one of the plurality of wires comprises a substantiallyrectangular cross-section. In a further aspect, the rectangularcross-section can have at least one of a height and a width of fromabout 60 to about 150 microns.

In yet another aspect illustrated in FIGS. 8A and 8B, the braidedscaffolding 228 can be further characterized by the number of wirecross-overs 500 a and 500 b per inch along the length of each wire ofthe plurality of wires, hereinafter referred to as “picks per inch.” Itis contemplated that the braided scaffolding can have from about 6 toabout 20 picks per inch, more preferably from about 7 to about 12 picksper inch, and, most preferably, about 9 picks per inch.

In yet another aspect, the braided scaffolding can be furthercharacterized by the pattern of relative “over” or “under” placement ofthe wire cross-overs along the length of each of the plurality of wires.In one exemplary aspect illustrated in FIG. 8A, the braided scaffoldingcomprises a one-on-one configuration, meaning that the wire cross-oversalong each of the plurality of wires alternate between one other wirecrossing over 500 a and one other wire crossing under 500 b each wire.In another exemplary aspect illustrated in FIG. 8B, the braidedscaffolding comprises a one-on-two configuration, meaning that the wirecross-overs along each of the plurality of wires has a pattern where twoother wires cross over and one other wire crosses under each wire orvice-versa. FIG. 7 shows two different braided configurations withvariations on the placement of the over versus under wires.

In another aspect illustrated in FIG. 9, each wire 600 of the pluralityof wires 230 can further comprise at least one crossover portion 602 andat least one non-crossover portion 604. Here, a crossover portion 602 ofa wire slidably contacts another wire of the plurality of wires 230 asthe filter 214 moves between and about the collapsed position 216 to thedeployed position 218. Correspondingly, a non-crossover portion 604 of awire 600 does not contact any of the other wires of the plurality ofwires 230 as the filter 214 moves between and about the collapsedposition 216 and the deployed position 218. In a further aspect, thefilter membrane 222 can be selectively attached to a plurality of thenon-crossover portions 604 of the plurality of wires 230 of the braidedscaffolding 228. In operation, selective attachment of the filtermembrane 222 to a plurality of the non-crossover portions 604 of theplurality of wires 230 of the braided scaffolding 220 ensures the filterchassis 220 can open uniformly and to its full deployed position.

Referring to FIGS. 1-7 and also to FIG. 9, in another aspect, the filterchassis 220 has a central portion 232 having a maximum radialdisplacement, or apex 234 from the collapsed position 216 when thefilter 214 is unconstrained and in the deployed position 218. It iscontemplated that the filter membrane 222 can be selectively attached tothe filter chassis 220 at a plurality of non-crossover portions 604 ofthe plurality of wires 230 of the braided scaffolding 228 located on oradjacent to the exterior of the apex 234 of the central portion 232 ofthe filter chassis 220.

Referring to FIGS. 1-7, another aspect, the filter membrane 222 canextend beyond the filter chassis 220 in a longitudinal directionrelative to the longitudinal axis of the catheter such that a sac 236 isformed to retain embolic particles when the filter is in the collapsedposition.

It is contemplated that the filter membrane 222 can comprise a polymer.In one aspect, the filter membrane 222 can be formed from polyurethane.In one aspect, the filter membrane 222 can be attached by thermal means,adhesive or by any other suitable attachment means known in the art.

As illustrated in FIG. 10, it is also contemplated that the filtermembrane 222 can comprise a braided mesh 700 operably coupled to thefilter chassis 220. In one aspect, the braided mesh 700 is disposed onan interior surface 702 of the filter chassis 220. In another aspect,the braided mesh 700 comprises about 64 wires. In another aspect, thebraided mesh 700 comprises N wires and is folded over to form anapparent mesh having 2N wires. In one exemplary aspect where the braidedmesh 700 comprises about 64 wires, the apparent braided mesh comprisesabout 128 wires. In another aspect, the braided mesh 700 comprises ashape memory material. In a further aspect, the shape memory material ofthe braided mesh 700 corresponds to the deployed position of the filter214 and the braided scaffolding 228 comprises shape memory materialhaving a shape memory corresponding to the collapsed position of thefilter 214. It is contemplated that such a filter can be particularlyuseful in relatively large vessels such as, for example and withoutlimitation, the aorta. It is also contemplated that such a filter canopen to diameters of up to about 50 mm. In operation, the filter mesh700 acts as a spring to aid in the selective expansion of the filter214.

In another aspect, the filter membrane 222 comprises from about a 40 toabout a 100 micron mesh, and more particularly from about a 40 to abouta 60 micron mesh, and, most particularly, from about a 50 micron mesh.It is further contemplated that the filter membrane 222 can have atolerance of about 10 microns.

It is further contemplated that at least one of the movable collar 224and the fixed collar 226 can comprise a polymer. In a further aspect,the polymer can comprise polyimide. In an even further aspect, aninterior surface of the movable collar 224 further comprises a coatinghaving a lower coefficient of friction that the movable collar materialand, even further, the coating can comprise, for example and withoutlimitation, PTFE and the like.

In another aspect, that the distal portion 238 of the movable collar 224can have a tapered portion that narrows toward the distal-most end ofthe movable collar 224.

In a further aspect, the movable collar 224 can be located distal to thefixed collar 226 relative to the longitudinal axis of the catheter 202.

In another aspect, the catheter 202 can further comprise a lumen 240 anda port 242 in communication with the lumen, the port comprising anaperture 211 in the outer side wall 210 of the catheter 202 located inbetween the fixed collar 226 and the movable collar 224, and the lumenextending from the proximal end portion 206 of the catheter to the port242.

It is contemplated that the device 200 further comprises an actuatorwire 246 having a proximal end 248 and a distal end 250, wherein atleast a portion of the actuator wire extends through the lumen of thecatheter 202, and wherein the distal end of the actuator wire exits thelumen of the catheter through the port and is coupled to the movablecollar 224.

In one operational aspect, when the filter 214 is in the collapsedposition 216, pulling on the proximal end 248 of the actuator wire 246exerts a force on the movable collar 224 in a direction relative to thelongitudinal axis 204 of the catheter 202 that moves the movable collar224 toward the fixed collar 226 and wherein selective movement of themovable collar 224 towards the fixed collar 226 causes a central portion232 of the filter chassis 220 to radially expand thereby selectivelyexpanding the filter 214 towards the deployed position 218.

In one aspect illustrated in FIGS. 11-15, the percutaneous transluminaldevice 200 comprises a handle 800 coupled to the proximal end of theproximal end portion 206 of the catheter 202 and operably coupled to theproximal end of the actuator wire 246. The handle has a longitudinalaxis 802 that can be coextensive with the catheter longitudinal axis. Asshown in FIGS. 14-15, the handle can further comprise a screw 804 havingat least one thread 806 disposed on an exterior surface 808 thereof,wherein the screw 804 can be coupled to the actuator wire 246; a handlebody 810 having a distal portion 812 and a proximal portion 814; and anactuator 816 coupled to the screw 804 and operably coupled to the handlebody 810. It is contemplated that the actuator 816 can be configured toeffect axial displacement of the screw 804, and, correspondingly, theactuator wire 246, relative to the handle longitudinal axis 802. In oneaspect, the actuator 816 can be a knob and the knob can be rotatablycoupled to the screw 804 along the longitudinal axis 802 of the handle800.

In another aspect, each of the distal portion 812 and a proximal portion814 of the handle body 810 can have respective inner surfaces thatcooperate to define a respective chamber 818, 820. In one aspect, theproximal portion 814 of the handle 800 can further comprise a distalstop 822, a proximal stop 824, and a plurality of thread-receivingmembers 826 for engaging the at least one thread 806 of the screwdisposed on an inner surface thereof and positioned between the distaland proximal stops 822, 824 relative to the handle longitudinal axis802. It is contemplated that the distal stop 822 can limit distal axialmovement of the screw 804 and the proximal stop 824 can limit proximalaxial movement of the screw 804.

In another aspect, the knob can be positioned between the distal portion812 and the proximal portion 814 of the handle body 810. Here, it iscontemplated that the proximal portion 814 and the distal portion 812 ofthe handle 800 are spaced apart along the handle longitudinal axis 802and the handle 800 further comprises at least one bridge portion 828extending between and connected to the proximal portion 814 and thedistal portion 812; wherein the proximal portion 814, distal portion 812and the bridge portion 828 cooperate to define an opening for receivingat least a portion of the knob. In one aspect, the knob can have a holeextending through the rotational axis of the knob and can furthercomprise a distal portion 830, a central portion 832, and a proximalportion 834. In one aspect, the distal portion 812 of the handle 800 canhave a proximal end 836 configured to receive at least a portion of thedistal portion 830 of the knob. It is contemplated that the distalportion 830 of the knob can be positioned in at least one of slidableand rotatable engagement with the proximal end 836 of the distal portion812 of the handle body 810. In another aspect, the proximal portion 814of the handle body 810 has a distal end 838 configured to receive aproximal portion 834 of the knob. Here, it is contemplated that theproximal portion 834 of the knob can be positioned in at least one ofslidable and rotatable engagement with the distal end 838 of theproximal portion 814 of the handle body 810.

In another aspect, the inner surface of the distal end 838 of theproximal portion 814 of the handle body 810 is inwardly tapered relativeto the handle longitudinal axis 802 from the distal end 838 to thedistal stop 822. It is further contemplated that the proximal portion834 of the knob further comprises an O-ring 840 fixed to the outersurface thereof. Here, it is further contemplated that the knob can alsobe slidably disposed in the bridge portion 828. In operation, slidingthe knob proximally relative to the handle longitudinal axis 802 cancause the O-ring 840 to engage the inwardly tapered inner surface of theproximal portion 814 which locks the rotational position of the knob.Conversely, sliding the knob distally relative to the handlelongitudinal axis 802 unlocks the knob and allows further rotation. Inoperation, this O-ring locking mechanism can enable a physician to lockthe filter 214 in any position about and between the collapsed position216 and the deployed position 218. It is contemplated that such afeature, in combination with the disclosed filter 214, can be useful toadjust the expansion of the filter 214 towards the deployed position 218and then secure the filter 214 in the selected position while the givenintervention is effected.

In another aspect, each thread of the at least one thread 806 has apitch 842. In one aspect, the pitch 842 of the at least one thread 806can be selected to produce a desired axial movement of the screw 804upon rotation. In a further aspect, the pitch 842 of the at least onethread can be selected to produce axial movement of the screw 804 alongthe handle longitudinal axis 802 equal to the circumferential movementof the knob.

In another aspect, the distal end of the distal portion 812 of thehandle body 810 can further comprise an opening disposed therein forreceiving the proximal ends of both the proximal portion of the catheter202 and the actuator wire 246. In a further aspect, the distal portion812 of the handle body 810 can further comprise a luer disposed thereinand operably coupled to the distal portion 830 of the knob. In a furtheraspect, the luer comprises at least one port. Here, it is contemplatedthat at least the actuator wire 246 passes through the luer, through atleast a portion of the hole disposed in the knob and is coupled to theactuator 816. In a further aspect, the actuator wire 246 can be coupledto the screw 804. In another aspect, the luer can comprise a second portand, in a further aspect, the second port can extend through a secondopening formed in the distal portion 812 of the handle body 810.

In operation, rotating the screw 804 in either a clockwise orcounterclockwise direction can move the actuator wire 246 back and forthalong the catheter longitudinal axis 204. As described above, theactuator wire 246 is coupled to the movable collar 224 of the filterchassis 220. Accordingly, selective rotation of the screw 804 causes themovable collar 224 to be displaced relative to the fixed collar 226along the catheter longitudinal axis 204. In a first rotationaldirection of the screw 804, the movable collar 224 is displaced towardthe fixed collar 226, expanding the filter 214 towards the deployedposition 218. In a second rotational direction of the screw 804, themovable collar 224 is displaced away from the fixed collar 226, movingthe filter 214 towards the collapsed position 216. Accordingly, oneskilled in the art will appreciate in light of the present disclosurethat selectively rotating the screw 804 enables a physician to adjustthe degree of expansion of the filter 214 to the target vessel. In oneaspect, the screw 804 is actuated via a knob disposed in the bridgeportion 828 of the handle 800 as described above. In a further aspect, aphysician can secure the filter 214 in any position about and betweenthe collapsed position 216 and the deployed position 218 by sliding theknob to engage the O-ring locking mechanism. It is contemplated thatsuch a feature, in combination with the disclosed filter 214, can beuseful to adjust the expansion of the filter 214 towards the deployedposition 218 and then secure the filter 214 in the selected positionwhile the given intervention is affected. As one skilled in the art willappreciate in light of the present disclosure, a physician (or any user)can selectively deploy the filter 214 and engage the O-ring lockingmechanism and vice-versa with a single hand.

In another aspect illustrated in FIG. 16, the present disclosuredescribes a percutaneous transluminal device substantially as describedabove but having a filter 214 comprising a filter chassis 220 comprisinga tubular braided scaffolding 228 having a distal end coupled to amovable collar that is slidably coupled to the catheter and having aproximal end that is coupled to a fixed collar that is spaced from themovable collar relative to the catheter longitudinal axis and immovablycoupled to the catheter. FIG. 16 provides from top left cornerclockwise: the filter 214 is shown in its initial collapsed state 216.The next figure shows the filter 214 is deployed in an arterial model950. The third figure shows the filter has captured particles 952. Thelast figure shows the filter 214 is now collapsed trapping the particles952 within the filter membrane 222.

In another aspect, the braided scaffolding can have a shape memory thaturges the filter into the collapsed position. It is further contemplatedthat the braided scaffolding can have a central portion having a maximalradial displacement from the catheter longitudinal axis, or apex, thatis greater than a target vessel radius when the filter is in thedeployed position. In one aspect, when the filter is in the collapsedposition, pulling on the proximal end of the actuator wire exerts aforce on the movable collar in a direction relative to the longitudinalaxis of the catheter that moves the movable collar toward the fixedcollar. It is contemplated that selective movement of the movable collartowards the fixed collar causes the filter to selectively expand,thereby allowing the filter to conformably appose an inner wall of thetarget vessel. In the selectively expanded configuration, the filtercaptures substantially 100% of embolic particles having a particle sizeof at least 150 microns while remaining substantially patent duringoperation of the angioplasty treatment device and at least until thefilter is collapsed for removal of the angioplasty device from thevessel. In another aspect, in the selectively expanded configuration,the shape of the conformably apposed filter and the pore size of thefilter membrane cooperate to capture substantially 100% of embolicparticles having a particle size of at least 150 microns while thefilter remains substantially patent for up to about 5 minutes, morepreferably, up to about 3 minutes, and, most preferably, up to about 1minute. FIG. 17 is a table showing membrane particulate captureefficiency test results for the percutaneous transluminal devicedescribed in this disclosure.

FIG. 18 shows the filter 214 in its deployed state inside the modelvessel 950. The filter conforms to the vessel walls and creates a tightseal so all particles are efficiently captured. FIG. 19 shows the filter214 in a bend. It depicts the flexibility of the filter 214 to navigatethrough tight bends.

In yet another aspect illustrated in FIG. 20, the present disclosuredescribes a percutaneous transluminal device 900 comprising an elongatedcatheter 902 having a longitudinal axis 904, a proximal end portion 906,a distal end portion 908, and an outer side wall 910; an interventionaldevice 912 operably coupled to at least the distal end portion of thecatheter, and a filter 914 operably coupled to the distal end portion ofthe catheter, wherein the filter can be selectively collapsible andexpandable about and between a collapsed position 216 and a deployedposition 918. In this aspect, it is contemplated that the percutaneoustransluminal device 900 can comprise any of the aspects described aboveand illustrated in FIGS. 1-19, unless otherwise noted herein. In oneaspect, the elongated catheter is further configured to have a secondlumen 920 disposed therein and adapted for slidably receiving at least aportion of a guidewire 922. It is further contemplated that theinterventional device 912 comprises an atherectomy device. Theatherectomy device can comprise a directional atherectomy device, arotational atherectomy device or a combination thereof. In anotheraspect, the elongated catheter 912 further comprises a first elongatecatheter 912 and a second elongate catheter 924 having a longitudinalaxis 926 coextensive with that of the first catheter 912, a proximal endportion 928, a distal end portion 930, and a lumen 932 disposed thereinfor slidably receiving at least a portion of the first elongate catheter912. It is contemplated that the interventional device 912 is disposedon the distal end portion 930 of the second catheter 924. In a furtheraspect, the interventional device 912 is located proximal to the filterwith respect to the longitudinal axis 904 of the first catheter 902.

It is contemplated that the first elongate catheter 902 can comprise apolymer. In a further aspect, for example and without limitation, thepolymer can comprise silicone, polyurethane, polyethylene, PTFE and thelike. Alternatively, it is contemplated that the first elongate catheter902 can comprise a metal. Here, it is contemplated that the metalcatheter can be, for example and without limitation, a 0.014″, 0.018″,0.035″ wire, having at least one and, preferably, two lumens disposedtherein.

Accordingly, FIGS. 1-20, and the corresponding text, provide a number ofdifferent artificial turf configurations, as well as the devices,methods to form the different artificial turf configurations. Inaddition to the foregoing, implementations described herein can also bedescribed in terms acts and steps in a method for accomplishing aparticular result. For example, a method comprising providing apercutaneous transluminal device according to the present disclosure,inserting the distal portion of the device into a vessel such that theinterventional device and the filter are located in a target location,deploying the integrated filter of the device, operating theinterventional device; collapsing the integrated filter, and withdrawingthe device from the body is described concurrently above with referenceto the components and diagrams of FIGS. 1-20.

The present invention can thus be embodied in other specific formswithout departing from its spirit or essential characteristics. Thedescribed aspects are to be considered in all respects only asillustrative and not restrictive. The scope of the invention is,therefore, indicated by the appended claims rather than by the foregoingdescription. All changes that come within the meaning and range ofequivalency of the claims are to be embraced within their scope.

What is claimed:
 1. A percutaneous, transluminal angioplasty devicecomprising: an elongated catheter having a longitudinal axis, a proximalend portion, a distal end portion and an outer side wall; aninterventional device operably coupled to the proximal end portion ofthe catheter; a filter operably coupled to the distal end portion of thecatheter, the filter movable between a collapsed position and a deployedposition, the filter comprising: a filter chassis comprising: a movablecollar slidably coupled to the catheter, a fixed collar spaced from themovable collar relative to the longitudinal axis of the catheter, thefixed collar immovably coupled to the catheter, a tubular braidedscaffolding having a first end coupled to the movable collar and anopposed second end coupled to the fixed collar, and a filter membranecoupled to the tubular braided scaffolding and extending to at least thedistal end of the filter chassis; and an actuator wire, at least aportion of the actuator wire extending within the catheter, a distal endof the actuator wire exiting the catheter through a port provided on anouter side wall of the catheter, a distal end of the actuator wire beingcoupled to the movable collar; a handle coupled to the proximal endportion of the catheter and operably coupled to a proximal end of theactuator wire at a screw, and an actuator coupled to the screw, theactivation of the actuator effecting axial displacement of the screw,and, correspondingly, the actuator wire, relative to the handlelongitudinal axis, the handle comprising a distal portion; a proximalportion including a distal stop, a proximal stop, and a plurality ofthread-receiving members for engaging the at least one thread of thescrew positioned between the distal and proximal stops relative to alongitudinal axis of the handle such that distal stop limits distalaxial movement of the screw and the proximal stop limits proximal axialmovement of the screw; and a bridge portion extending between andconnected to the proximal portion and the distal portion, whereinrotation of the screw causes the actuator wire to move along thelongitudinal axis of the catheter, where movement of the actuator wirecauses the filter to move between the collapsed position and thedeployed position by exerting a force on and moving the movable collarrelative to the fixed collar along the longitudinal axis of thecatheter.
 2. The device of claim 1, wherein during a first rotationaldirection of the screw, the movable collar is displaced toward the fixedcollar, expanding the filter towards the deployed position, and during asecond rotational direction of the screw, the movable collar isdisplaced away from the fixed collar, moving the filter towards thecollapsed position.
 3. The device of claim 1, wherein a distal portionof the actuator is positioned in at least one of slidable and rotatableengagement with a proximal end of the distal portion of the handle,wherein a proximal portion of the actuator is positioned in at least oneof slidable and rotatable engagement with a distal end of the proximalportion of the handle.
 4. The device of claim 1, wherein an innersurface of the distal end of the proximal portion of the handle body isinwardly tapered relative to the handle longitudinal axis, wherein aproximal portion of the actuator further comprises an O-ring fixed tothe outer surface thereof, the actuator slidably disposed in the handlesuch that sliding the actuator proximally relative to the handlelongitudinal axis causes the O-ring to engage the inwardly tapered innersurface of the proximal portion thereby locking a rotational position ofthe actuator.
 5. The device of claim 1, wherein the movable collar isslidably coupled to the catheter proximate the distal end portion of thecatheter and the fixed collar is coupled to the catheter at a locationbetween the movable collar and the proximal end portion of the catheter.6. The device of claim 1, wherein when the filter is in the collapsedposition, pulling on the proximal end of the actuator wire exerts aforce on the movable collar in a direction relative to the longitudinalaxis of the catheter that moves the movable collar toward the fixedcollar such that the filter chassis expands radially thereby expandingthe filter toward the deployed position, and wherein, when the filter isin the deployed position, pushing on the proximal end of the actuatorwire exerts a force on the movable collar in a direction relative to thelongitudinal axis of the catheter that moves the movable collar awayfrom the fixed collar such that the filter chassis contracts radiallythereby contracting the filter toward the collapsed position.
 7. Thedevice of claim 6, wherein as a distance between the movable collar andthe fixed collar along the longitudinal axis of the catheter isdecreased, a central portion of the tubular braided scaffolding radiallyexpands, causing the filter to expand towards the deployed position. 8.The device of claim 7, wherein the central portion defines a maximumradial displacement of the tubular braided scaffolding from the catheterlongitudinal axis, wherein the maximum radial displacement is greaterthan a target vessel radius when the filter is in the deployed position.9. The device of claim 1, wherein when the filter is in the deployedposition, the filter chassis is sized and configured to conform to ashape of a target vessel over a length of the target vessel.
 10. Thedevice of claim 1, wherein the filter in the deployed position capturessubstantially 100% of embolic particles having a particle size of atleast 150microns while remaining substantially patent during operationof the interventional device and at least until the filter is collapsedfor removal of the interventional device from the vessel.
 11. The deviceof claim 1, wherein the tubular braided scaffolding further comprises aplurality of wires and each wire of the plurality of wires movesindependently with respect to the other wires between the movable collarand the fixed collar as the filter moves between the collapsed positionand the deployed position.
 12. The device of claim 11, wherein each ofthe plurality of wires of the tubular braided scaffolding is formed froma shape memory material.
 13. The device of claim 12, wherein the tubularbraided scaffolding can have a shape memory corresponding to thecollapsed position of the filter.
 14. The device of claim 11, wherein atleast one of the wires of the plurality of wires is formed from a shapememory material and a remainder of the plurality of wires is formed froma non-shape memory material.
 15. The device of claim 11, wherein eachwire of the plurality of wires extends between the first and second endsof the braided scaffolding, wherein each wire of the plurality of wiresfurther comprises at least one crossover portion and at least onenon-crossover portion.
 16. The device of claim 15, wherein the tubularbraided scaffolding includes from about 6 to about 20 wire crossoverportions per inch along a length of at least on the plurality of wires.17. The device of claim 15, wherein the tubular braided scaffoldingincludes alternating crossover portions and non-crossover portions alongeach of the plurality of wires.
 18. The device of claim 15, wherein thetubular braided scaffolding includes a one-to-two ratio of alternatingcrossover portions and non-crossover portions along each of theplurality of wires.
 19. The device of claim 15, wherein the crossoverportion of a wire of the plurality of wires slidably contacts anotherwire of the plurality of wires as the filter moves between the collapsedposition and the deployed position.
 20. The device of claim 15, whereinthe filter membrane is coupled to the at least one non-crossoverportion.
 21. The device of claim 20, wherein the filter membrane iscoupled a non-crossover portion provided at a location proximate amaximum radial displacement of the filter chassis when in the deployedposition.
 22. The device of claim 1, wherein the filter membrane extendsbeyond the filter chassis in a longitudinal direction relative to thelongitudinal axis of the catheter.
 23. The device of claim 1, whereinthe filter membrane comprises a braided mesh operably coupled to thefilter chassis.
 24. The device of claim 23, wherein the braided mesh isdisposed an interior surface of the filter chassis.
 25. The device ofclaim 23, wherein the braided mesh is a dual layer braided mesh.
 26. Thedevice of claim 23, wherein the braided mesh comprises a shape memorymaterial having shape memory corresponding to deployed position of thefilter, wherein the tubular braided scaffolding comprises a shape memorymaterial having a shape memory corresponding to the collapsed positionof the filter.
 27. The device of claim 23, wherein the braided meshcomprises a polymer.
 28. The device of claim 23, wherein the braidedmesh has a pore size of less than 100 microns.
 29. The device of claim1, wherein the catheter further comprises a lumen and a port incommunication with the lumen, the port comprising an aperture in theouter side wall of the catheter located in between the fixed collar andthe movable collar, and the lumen extending from the proximal endportion of the catheter to the port, wherein the actuator wire extendsthrough the lumen, the distal end of the of the actuator exiting thelumen through the port.
 30. The device of claim 1, wherein movement ofthe movable collar toward the fixed collar causes a central portion ofthe filter chassis to radially expand.
 31. The device of claim 1,wherein the interventional device is an angioplasty device, theangioplasty device including at least one of an angioplasty balloon, astent, a mechanical thrombectomy device, an atherectomy device.
 32. Thedevice of claim 31, wherein the atherectomy device includes at least oneof a rotational atherectomy device, a directional atherectomy device,and a combination rotational-directional atherectomy device.
 33. Thedevice of claim 1, wherein the interventional device can perform atleast one of an angioplasty, a valvuplasty, and an ablation.